Services - Efficacy and residue trials management

Context:

To obtain the registration of a plant protection Product ‘or’ Extension of an existing registered Product for New Uses, authorities ask for regulated efficacy, selectivity and residue trials in sufficient number and in relevant locations.

Efficacy and selectivity trials as a minimum are required to be conducted by Officially Recognised Efficacy Testing Facilities (ORETO) in accordance with Good Efficacy Practice (GEP) following specific European guidelines (EPPO) and may have additional national methods eg. CEB methods in France. Additionally, in France, trials which are intended for the registration dossier have to be declared onto the Coleor system from the Ministry of Agriculture. Throughout the European Union (EU) Residue Trials must be carried out to Good Laboratory Practice (GLP) standard by a certified facility and have to be conducted following the OECD guidelines.

At your request, A.S.C. can:

  • identify the necessary trials including number and geographical positioning
  • manage your trials discussing protocols, time-frame and costs with the CRO's
    • declare the French registration trials in Coleor
    • ensure trials and analyses run smoothly
    • visit field trials
    • review the draft reports to ensure a precise final report
  • summarise relevantly and clearly the whole data package in a BAD
  • present in a convincing way the biological properties of your formulated product
  • liaise with Authorities, if necessary, before or after the dossier submission until the approval is granted.
Services

 

Classifications
Labelling
SDS

 

Efficacy and residue trials management

 

GLP inspections and audits

 

Regulatory survey
Training

 

Modelling
Risk assessment

 

Prepare your IUCLID 5 dossiers
A.S.C. - Les Chevrières 71570 CHAINTRÉ FRANCE - tel : + 33 (0)3 85 35 67 14 - fax: + 33 (0)3 85 35 01 04 - Contacts- Site map